The InfiMed i?™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i-TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed is TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i2m Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

Device Description

The InfiMed if TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i " Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, Trixell Pixium RF4343. Varian PaxScan 4343CB), computer, monitor, and the digital imaging system.

AI/ML Overview

The provided text describes a 510(k) submission for the Varian Medical Systems Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of diagnostic accuracy or impact on human readers.

Here's a breakdown of the requested information based on the provided text, along with notes on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent or better image quality than predicate device	"delivers equivalent or better image quality as the predicate device."
Performance of functions performed by predicate device	"The comparison chart reveals that functions performed by the predicate device are performed by the modified i^2TM Digital X-ray Imaging System."
No new indications for use	"has no new indications for use"
No significant technological differences	"has no significant technological differences"
As safe and effective as predicate	"is as safe and effective as the predicate device"
Does not raise different questions of safety and effectiveness	"does not raise different questions of safety and effectiveness"
All release criteria met (from validation protocols)	"all release criteria have been met"

Note: The document states that "Validation was completed in accordance with the Validation Protocols included with this submission" and that "Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria." However, the specific acceptance criteria and quantitative results of these validation protocols are not provided in the summary. The acceptance criteria above are implied from the statements about "substantial equivalence."

2. Sample size used for the test set and the data provenance

The document does not provide details about a specific "test set" in the context of a clinical performance study with human readers or diagnostic accuracy. It mentions "Clinical Data submitted is consistent with FDA guidance document 'Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices'." This suggests that any clinical data submitted would be in line with general requirements for imaging devices, but specific details about a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The submission focuses on demonstrating technical equivalence and safety/effectiveness relative to a predicate, not on a new clinical study involving expert interpretation for ground truth establishment.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was done, especially one involving "AI assistance." The device is described as a "Digital X-ray Imaging System," and the "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques." This refers to standard image processing, not necessarily AI in the modern sense, and no comparative effectiveness study results are given.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

There is no indication that a standalone algorithm performance study was conducted or reported in this summary. The device is an imaging system, not a diagnostic AI algorithm in itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for any clinical performance evaluation. Given the nature of a 510(k) for an imaging system upgrade (adding a new receptor), the clinical data likely involves demonstrating image quality and diagnostic utility in comparison to the predicate, rather than establishing new ground truth for specific pathologies.

8. The sample size for the training set

This information is not provided in the document. The device is an imaging system, and while it has image processing algorithms, the concept of a "training set" in the context of modern machine learning algorithms used for diagnostic purposes is not explicitly discussed or applicable here.

9. How the ground truth for the training set was established

This information is not provided in the document, and the concept of a training set ground truth is not applicable given the details provided.

In summary:

This 510(k) summary is primarily focused on demonstrating substantial equivalence of a modified digital X-ray imaging system to an existing predicate device, largely based on technological characteristics and the claim of equivalent or better image quality. It does not contain the detailed clinical study information (sample sizes, expert qualifications, ground truth methods, MRMC studies, or AI performance metrics) that would be expected for a submission involving a novel diagnostic AI algorithm or a device requiring new clinical performance claims beyond equivalence to a predicate. The "clinical data" referenced is likely related to general image quality and functional performance as per the FDA guidance for solid-state X-ray imaging devices, rather than a specific study comparing diagnostic accuracy.

Summary

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VARIAN
medical systems

A partner for life

APR 2 2 2013

K130318
Page 1 of 2

Section 3: 510(k) Summary

Date Prepared:	02/07/2013
Contact Person:	Catherine MulcahyRegulatory Affairs Manager
Telephone:Fax:	315-453-4545 x288315-453-4550
Submitter Name:	Varian Medical Systems, X-Ray Products - InfiMed121 Metropolitan DriveLiverpool, NY 13088
Device Trade Name:	Nexus DRF Digital X-ray Imaging System (withPaxScan 4343CB)
Common Name:	Digital X-ray Imaging System
Classification Name(s):	Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB)JAA, MQB
Product Codes:	JAA, MQB

Predicate Device:	510(k) Number:	Product Codes:
Nexus DRF Digital X-ray Imaging System	K103416	JAA, MQB

Device Description:

Intended Use:

The i TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i2TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic

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A partner for life

K130318
Page 2 of 2

details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i-TM Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed ison Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

Technological Characteristics Comparison:

The modified device supports the same modalities as the predicate device with the same components or imaging concepts, and delivers equivalent or better image quality as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the modified is TM Digital X-ray Imaging System. The modified device, Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB), has the ability to interface with an additional image receptor, Varian PaxScan 4343CB. Therefore, the modified device is substantially equivalent to the predicate device.

Non-clinical Tests Discussion:

Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the modified if TM Digital Xray Imaging System is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

Clinical Tests Discussion:

Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.

Conclusion:

Based upon the results of Verification and Validation testing, the Nexus DRF Digital Xray Imaging System (with PaxScan 4343CB) has no new indications for use, has no significant technological differences, and is as safe and effective as, does not raise different questions of safety and effectiveness and is therefore substantially equivalent to the above listed current legally marketed predicate device.

121 Metropolitan Park Drive, Liverpool, New York 13088 Main Document - Page 9 of 32

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2013

Varian Medical Systems, X-Ray Products - InfiMed % Ms. Catherine Mulcahy Regulatory Affairs Manager 121 Metropolitan Drive LIVERPOOL NY 13088

Re: K130318

Trade/Device Name: Nexus DRF Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA, MQB Dated: February 28, 2013 Received: March 7, 2013

Dear Ms. Mulcahy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning vour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Mulcahy

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janing M. Messa

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130318

Device Name: Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB)

Indications for Use:

For the DR application, the InfiMed is TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i2m Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Flaming H. Herse

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)	K130318
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Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.